# K974658: Infrared Group Amplification System, Infrared Emitter, Infrared Body Worn Receiver, Infrared Headset Receiver-Stereo, IT

- Pathway: 510(k) (Traditional)
- Applicant: Phonic Ear, Inc.
- Decided: Feb 25, 1998 after 72 days
- Product code: EPF (Hearing Aid, Group And Auditory Trainer)
- Device class: 2
- Regulation: 21 CFR 874.3320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Model PE 600 Series devices form the Impaired Group Amplification System which is used by adults and children in public halls, theaters, churches, courtrooms and other public gatherings and provide auditory assistance to hearing impaired persons. The Model PE 600E is a power amplifier which is combined with an infrared LED array. Audio signals from a sound system are processed and broadcast into the listening area by means of infrared light. The PE B800R is a body worn infrared receiver. It receives the infrared light signals from the PE 600E and converts these signals to high level audio signals required by the hearing impaired listener. The audio signals can be adjusted to meet the needs of the user. The PE 601R is an Infrared Headset Receiver. It receives the infrared light signals from the PE 600E and converts these signals to audio signals required by the hearing impaired listener. This devise is capable of stereo reception so that different audio signals can be received simultaneously and fed to each ear separately. The PE 602R is an Infrared Headset Receiver. It receives the infrared light signals from the PE 600E and converts these signals to audio signals required by the hearing impaired listener. The device is capable of receiving infrared light signals transmitted on two separate frequencies. A switch on the headset allows the user to select the program frequency desired. The selected program is heard in each ear.

Source page: https://510kreport.com/device/K974658
Methodology: https://510kreport.com/methodology